Screening to Improve Survival in AL Amyloidosis

Overview

The purpose of this study is to see whether certain genes may be linked with the development of AL amyloidosis in subjects 60 years of age or older with the blood disorders SMM and MGUS. A limited repertoire of immunoglobulin (Ig) variable region genes have been associated with AL amyloidosis. The clonal plasma cells of subjects with SMM and MGUS may express one of these Ig variable region genes indicating a risk of progression to AL amyloidosis and potentially enabling early diagnosis. We hope this study will help us begin to understand whether Ig variable region gene identification can be a useful tool for assessing a subject's risk of progression to AL amyloidosis.

SparkCures ID 1103
Trial Phase Observational Trial
Enrollment 50 Patients
Trial Sponsors
  • Tufts Medical Center Cancer Center
NCT Identifier

NCT04615572

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Patients 60 years of age and older diagnosed with λ LC MGUS or λ LC SMM with dFLC greater than 23 mg/L and κ::λ free LC ratio below normal

Exclusion Criteria:

  • Patients with κ LC MGUS or κ LC SMM or amyloid in the bone marrow or in other biopsies will not be included.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

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Tufts Medical Center Cancer Center

Boston, MA

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

California

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Florida
Massachusetts
Tufts Medical Center Cancer Center

Boston, MA

New York
North Carolina
Verified UNC Lineberger Comprehensive Cancer Center University of North Carolina

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Resources

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